On September 12, 2023, Rocket Pharmaceuticals, Inc. (the "Company") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Leerink Partners LLC and Cowen and Company, LLC, as representatives of the several underwriters named in Schedule A thereto (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell up to (i) 7,812,500 shares of common stock (the "Shares"), and (ii) pre-funded warrants (the "Pre-Funded Warrants") to purchase 3,126,955 shares of common stock (the "Offering") (Press release, Rocket Pharmaceuticals, SEP 12, 2023, View Source [SID1234635184]). In addition, the Company granted the Underwriters a 30-day option to purchase up to an additional 1,640,918 shares of its common stock (the "Option Shares").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Underwriters exercised their option to purchase the Option Shares in full, and the Offering closed on September 15, 2023.

The Shares and the Option Shares were sold in the Offering at the public offering price of $16.00 per share and were purchased by the Underwriters from the Company at a price of $15.04 per share. The Pre-Funded Warrants were sold at a public offering price of $15.99 per Pre-Funded Warrant, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such Pre-Funded Warrant. Each Pre-Funded Warrant is exercisable as of September 15, 2023 until fully exercised, subject to an ownership limitation pursuant to the Underwriting Agreement.

The Offering was made pursuant to the Company’s effective registration statement on Form S-3 (Registration No. 333-253756), which was previously filed with the Securities and Exchange Commission under the Securities Act of 1933, as amended (the "Securities Act"), and declared effective on September 10, 2021.

The net proceeds from the Offering, after (i) giving effect to the Underwriters’ full exercise of their option to purchase the Option Shares and (ii) deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company, are expected to be approximately $188.9 million. The Company currently intends to use the net proceeds from the offering primarily to fund the further development of its pipeline of gene therapies for rare diseases, including the advancement of RP-A501 into a Phase 2 clinical trial and the continued clinical development of RP-A501, to accelerate the development of in-house manufacturing capabilities, and for general corporate purposes. The Company may also use a portion of the net proceeds to in-license, acquire or invest in complementary businesses or products. However, the Company currently has no agreements or commitments to complete any such transaction.

Pursuant to the Underwriting Agreement, the Company’s executive officers and directors, and certain other shareholders entered into agreements in substantially the form included as an exhibit to the Underwriting Agreement, providing for a 90-day "lock-up" period with respect to sales of the Company’s common stock, subject to certain exceptions.

The foregoing is a summary description of the Underwriting Agreement and is qualified in its entirety by the text of the Underwriting Agreement attached as Exhibit 1.1 to this Current Report on Form 8-K and incorporated herein by reference.

The form of Pre-Funded Warrant is filed as Exhibit 4.1 to this report and the description of the terms of the Pre-Funded Warrants is qualified in its entirety by reference to such exhibit.

A copy of the opinion of K&L Gates LLP relating to the validity of the Shares, the Option Shares and the Pre-Funded Warrants issued in the Offering is filed herewith as Exhibit 5.1.

On September 12, 2023, Harpoon Therapeutics, Inc. (the "Company") received a Notice of Termination (the "Notice") from AbbVie Biotechnology Ltd ("AbbVie") terminating the Development and Option Agreement, dated November 20, 2019, by and between the Company and AbbVie (the "Agreement") (Filing, 8-K, Harpoon Therapeutics, SEP 12, 2023, View Source [SID1234635137]). AbbVie stated in the Notice that it will not exercise the exclusive license option under the Agreement, which granted AbbVie an option to a worldwide, exclusive license to the Company’s HPN217 program, which targets B cell maturation antigen. In accordance with the Agreement and the Notice and by mutual agreement of the Company and AbbVie, the termination of the Agreement will be effective on October 13, 2023. The aforementioned HPN217 program has been and will remain exclusively owned by the Company, and the Company plans to complete the ongoing Phase 1 clinical trial with data to support the next phase of development.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On September 12, 2023 Calidi Biotherapeutics, Inc., (approved for listing on NYSE American under "CLDI"), a clinical-stage biotechnology company that is developing a new generation of targeted immunotherapies, reported that Allan Camaisa, CEO and Chairman of the Board, and Stephen Thesing, Chief Business Officer, will participate in a fireside chat at the upcoming Baird Global Healthcare Conference on Wednesday, September 13, 2023, at 7:55 a.m. ET (Press release, Calidi Biotherapeutics, SEP 12, 2023, View Source [SID1234635130]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On September 12, 2023 Exai Bio reported non-small cell lung cancer (NSCLC) data further validating that its novel RNA- and generative AI-based liquid biopsy platform detected early-stage disease with high accuracy (Press release, Exai Bio, SEP 12, 2023, View Source [SID1234635129]). The study of nearly 900 subjects demonstrated stage I sensitivity was 95% at 90% specificity. The use of Exai’s proprietary generative AI technology, derived from large independent datasets of tumor and blood samples, enhanced both sensitivity and specificity beyond what is achievable using standard machine learning techniques. The high detection of stage I tumors could have major clinical implications to enable earlier disease detection at initial diagnosis as well as molecular residual disease (MRD) monitoring.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Today’s study also revealed the platform’s novel capability to subtype cancer biology using a routine blood draw. In a pilot sub-study including 100 NSCLC patients, cell-free RNA patterns were used to distinguish adenocarcinoma from squamous cell carcinoma. The accuracy of Exai’s prediction was equivalent to tissue subtyping, highlighting the potential to use a blood-based test in lieu of or in conjunction with surgical pathology. Beyond this initial technology demonstration, Exai’s platform enables further novel insights into cancer transcriptional activity for clinical monitoring as well as in accelerating drug development programs for the biopharmaceutical industry. These results will be presented today at the 2023 World Conference on Lung Cancer (WCLC).

"Earlier lung cancer detection could lead to better treatment options and improved outcomes, however, finding small tumors and early-stage disease is still a major clinical challenge," stated Sandip Patel, Professor, Medical Oncology, University of California, San Diego. "Blood-based tests for the accurate and sensitive detection of lung cancer could significantly improve patient care, especially as new therapies are utilized in the neoadjuvant and adjuvant setting for treating non-small cell lung cancer."

"Over the past year, Exai has generated compelling evidence demonstrating that our innovative liquid biopsy platform can detect cancer at the earliest stages and shed insights into cancer biology," stated Pat Arensdorf, CEO of Exai Bio. "Based on strong results across multiple studies, we are actively developing a range of blood tests that aim to detect, define and monitor cancer at the earliest actionable stage for patients."

Exai’s platform uses the latest next generation sequencing techniques to generate a comprehensive profile of cell-free RNA and identify a novel category of cancer-associated, small non-coding RNAs, termed orphan non-coding RNAs (oncRNAs). OncRNAs are transcribed and actively secreted from cancer cells and are stable and abundant in the blood of cancer patients. Exai has created a catalog of hundreds of thousands of oncRNAs and tens of thousands of patient oncRNA profiles, spanning all major cancer subtypes. When combined with Exai’s proprietary artificial intelligence, this unique platform has several scientific and practical advantages over tests that focus on circulating tumor DNA (ctDNA) including sensitivity, specificity, and informative properties for active cancer biology.

Exai’s universal platform can be used across multiple cancer care settings such as screening and early detection, monitoring, molecular residual disease and therapy selection.

World Conference on Lung Cancer Presentation Details

Presentation Title: AI-Based Early Detection and Subtyping of Non-Small Cell Lung Cancer from Blood Samples Using Orphan Non-Coding RNAs

Session Title: Emerging Technologies in Lung Cancer Screening

Date: Monday, 9/11/23, 9:00 pm PDT

Authors: M. Karimzadeh, T. Cavazos, J. Wang, M. Multhaup, Y. Fang, J. Ku, J. Wang, X. Zhao, K. Wang, R. Hanna, O.I. Afolabi, A. Huang, D. Corti, K. Garcia, T. Joshi, D. Nguyen, Y. Kong, P. Arensdorf, K. Chau, A. Hartwig, H. Li, S. Patel, H. Goodarzi, L. Fish, F. Hormozdiari, B. Alipanahi

On September 12, 2023 RS Oncology, a clinical stage biotechnology company developing innovative therapies to eradicate mesothelioma and other diseases, reported the completion of the Phase 1 dose escalation portion of the MITOPE study (NCT05278975) (Press release, RS Oncology, SEP 12, 2023, View Source [SID1234635128]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The United Kingdom-based multicenter study met its primary objective of evaluating the safety and tolerability of RSO-021, a novel irreversible inhibitor of mitochondrial PRX3, in patients with malignant pleural mesothelioma and local disease affecting the lining of the lungs. These patients also had fluid on their lungs due to the cancer, which had failed to respond to at least one prior treatment.

"Concluding Phase 1 is a significant accomplishment towards bringing a potential new therapy to patients suffering from mesothelioma and other cancers of the lung," said Jarrett Duncan, CEO of RS Oncology. "We thank the patients, caregivers, support groups and the clinical hospital teams who are participating and supporting our program around the UK." "We look forward to sharing the full results of Phase 1 at a major cancer conference in 2024, as we continue our progress towards bringing this exciting new treatment to more patients," added George Naumov, COO of RS Oncology.

For additional information about the trial, please visit www.clinicaltrials.gov using the identifier #NCT05278975.